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NCT07383649 · ClinicalTrials.gov registry record · Phase 2
Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection
A Phase 2 study of CMV Viremia and Brain Cancer Metastatic, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT07383649: Recruiting Phase 2 study of CMV Viremia and Brain Cancer Metastatic, sponsored by The Methodist Hospital Research Institute.
NCT07383649 is a Phase 2 study of CMV Viremia and Brain Cancer Metastatic that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07383649, a Phase 2 study of CMV Viremia and Brain Cancer Metastatic, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female patients, aged ≥18 years, who have metastatic breast cancer with progressive brain metastases and CMV viremia (\> 250 copies/ml) or positive CMV IgG or IgM will be eligible to participate in the trial. Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon/radiation oncologist. At least 10 patients will be enrolled in the initial safety lead-in followed by the Phase II trial which will include 18 patients. Anti-HCMV therapy, oral Valganciclovir will be given to patients at 900 mg twice a day for 2 weeks. After the induction period, the maintenance will be continued with valganciclovir at 450 mg twice daily for 4 weeks (28 days).
Primary Outcome
To estimate the CNS objective response rate (RANO-BM and RECIST V1.1) with anti-HCMV therapy and standard-of-care in metastatic breast cancer patients with progressive brain metastases and CMV viremia or positive CMV IgG or IgM.
Conditions Studied
Interventions
- DRUG Valganciclovir
Study Locations (1)
Texas
- Houston Methodist Neal Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2026-03 |
| Est. Completion | 2030-05 |
| Phase | Phase 2 |
What NCT07383649 shows while recruiting
NCT07383649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with CMV Viremia appearing as the primary indexed condition, and to 1 intervention - of which Valganciclovir is the first listed.
NCT07383649 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07383649 about?
NCT07383649 is a clinical study titled "Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection". This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female pati...
What is the current status of trial NCT07383649?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2026-03. Estimated completion is 2030-05.
What conditions does trial NCT07383649 study?
This clinical trial studies the following conditions: CMV Viremia, Brain Cancer Metastatic.
What interventions are being tested in trial NCT07383649?
The interventions under investigation include: Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT07383649?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07383649 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07383649's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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